JPS6164234A - Needle assembly for collecting liquid specimen - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION This invention relates to the invention described in U.S. Patent Application No. 562,309, filed December 6, 1983, which is hereby incorporated by reference in its entirety. It is incorporated into.

The invention is herein incorporated into an assembly for collecting a fluid sample from a patient, such as a blood sample.

More particularly, the present invention relates to needle assemblies that collect single or multiple fluid samples from a patient using a single assembly.

This arrangement utilizes a sample chamber with transparent or semi-transparent walls to inspect whether adequate access to the desired sample source has been achieved.

Additionally, a highly absorbent material for water-containing solutions is used in a generally cylindrical sleeve to absorb gas displaced by the liquid sample moving into the housing chamber, once exposed to the liquid sample. The material swells immediately to prevent the liquid sample from exiting the No-Ujifugu chamber. The sleeve is cut from a solid, compressed material and is sized to allow air to flow out and pass between the wall of the sleeve and the adjacent wall of the housing containing the sleeve. . This material fuses with the liquid to close the outflow passage.

As explained in the aforementioned co-pending application, the tarnod forming a cylindrical sleeve is adapted to seal the chamber against evacuation of the sample while at the same time allowing the passage of gas displaced by the sample. Once the entrance to the liquid sample has been made, as indicated by the transparent or translucent chamber walls to observe the presence of the sample in the housing chamber, multiple samples can be sequentially passed from the housing chamber into multiple vacuum collection devices. It can be collected by pulling it out.

This assembly houses a separate flexible self-sealing elastomeric sleeve which cooperates with the evacuation opening of the vacuum collection device during exchanges of the device for sequentially ejecting different samples.

Co-pending Application No. 562,309 Saimei,
When using the compressed tablet sleeve embodiment described in Book 1+83, the radial gap present in the assembly allows the gap to be pushed to one side to provide a much larger opening for flow than when the gap is concentric. It has been found that tablets can be moved. This can also happen simply due to gravity.

Regardless, this causes an instantaneous non-uniform response to the initial volume of blood) and has the effect of slightly delaying the occlusion of blood flow during the process of directing initial venous entry to collect a blood sample.

In contrast, the present invention places the tablet cylinder or sleeve on a tapered nozzle post. The taper is such that the diameter of the hub post increases toward the suction end of the device. This keeps the tablet sleeve axis concentric with the cooperating boss axis, creating a device that responds uniformly over the front circumference to the sample. Therefore, the sleeve is d
Once venous entry is achieved, there is a uniform response in the initial venting shape of the air pocket in the assembly.
Immediately and almost simultaneously before attaching the evacuated sample receiving tube to the negative cannula end of the assembly, the pressure wired sleeve material swells to occlude blood flow. Thus, at the moment blood contacts the sleeve, the sleeve expands uniformly and concentrically around its hub post by absorbing water from the blood sample to prevent movement past the sleeve.

As mentioned above, it is desirable to provide a mechanism by which the user of the needle assembly can be told when the intravenous needle has entered a sample collection source, such as a patient's vein, from which a blood sample is to be collected. . In many cases where blood is drawn from a patient, locating the vein is stuck and there is insufficient blood flow to the sampling device due to ponding reasons. In these cases, it is advantageous to quickly determine that a vein has been entered so that the decision to direct blood into the needle assembly can be made quickly. Once this determination has been made and a venous entry≠5 has been made, "insert the evacuated blood collection container into the collection assembly according to known blood sample collection methods during a collection operation consisting of a single venous entry." You can.

The present invention is directed to solving one of the problems that occurs during venipuncture: the presence of air pockets in various needle assemblies. When performing venipuncture,
Because the evacuated blood collection container has not yet been attached to the opposite end of the structure, blood will flow into the needle assembly due to the air pocket remaining inside the needle assembly under normal pressure conditions. I can't do it. Therefore, even if a vein is entered, blood will not begin to flow simply due to obstruction of air pockets in the assembly.

U.S. Patent No. 4.207, assigned to a common assignee with this application.
, 870 and 4,398.544,
Porous plugs are used in blood collection assemblies of the type described herein. All of these devices use materials that are air permeable but liquid impermeable.

Both of these patents describe inventions employing relatively complex valve grooves and internal components.

Although these inventions allow for the use of porous materials to allow the passage of air that is displaced during storage of blood samples,
There is still room for improvement in such devices.

That is, although treatment by physical closure is generally effective, it is not always possible to achieve complete sealing.

In the present invention, by contrast, the material is in the form of separate sleeves or tablets, and the V of the two parts forms the housing during assembly on the production line. Ijr can be inserted mechanically. The present device is a simplified structure consisting of a cylindrical highly water-absorbing material that swells upon contact with an aqueous substance. The material is a highly absorbent material which is pressed into a sleeve-like cylindrical tablet which is mechanically inserted between the two parts forming the housing. Those skilled in the art of manufacturing multiple blood collection assemblies will appreciate that these cylinders can be manufactured separately in large numbers and inserted between two parts forming the housing on a mass production line. , These processes are all handled by robots.

Prior to a detailed description of the present invention, it is important to note that the materials forming the generally cylindrical vent sleeve of the present invention are manufactured by Grain Processing Corporation.
Corporation, 1600 Oregon St, Muscatine, Iowa.
) 52761 product Water Lock (WAT
ER-LOCK) A100. or water lock A
It should be noted that it may also consist of a hydrolyzed starch-polyacrylonitrile graft copolymer having side chains containing carboxamide and carboxylate groups such as 125. Other material sources include Henkel Corporation.
n), 4620 West 77th Street.

Minneapolis, Minenta (
(Minnesota) Varnish-Super Absorbent Company (SuperAbsorbent Compa)
Route 3 + PO Box 342, Lumberton, North Carolina: and Edison H%rocontr
ol Chemicals Inc.), 99? There is 10016 Madison On Avenue, New 'f'ork.

The water-absorbing HO IJ mom composition of the present invention is disclosed in U.S. Pat.
．． No. 045,387, No. 4,134,863, No. 3,
No. 981,100.

No. 4.159,260, No. 3.6 f51,815, No. 3,935,099 and No. 3,985,616
It can be manufactured by the method described in No.

Referring to the drawings, like reference numerals refer to like parts throughout the several figures. FIG. 1 shows a housing 12, a first intravenous needle (V) for insertion into a patient;
) a cannula 14 and a second vacuum needle cannula 15 at the opposite end of the housing 120;
The basic external components of

The second needle cannula 15 is suitable for insertion into an evacuated or negative pressure container 16 from which a blood sample is to be collected. Those skilled in the art will appreciate that the two-needle assembly L4.
It will be appreciated that as an alternative to 15, a single-needle structure extending through the assembly may be used. The twin needle assembly described is merely a detailed illustration of the invention.

The housing 12 has a vacuum boss 25 with a thread L8 near the second cannula, onto which the container holder 19 is screwed by a thread 20 that engages inside the front end of the holder. The evacuated container [6 is inserted into the holder 19 so that the second needle cannula 15 pierces the stopper 21 at the front end of the evacuated container 16. The one-step appearance of these blood sample collection assemblies is
Well known to those skilled in the art.

Referring to FIG. 2, vacuum boss portion 25 of housing 12 is shown. The negative pressure boss includes a cylindrical portion 111 adapted to cooperate with the anterior intravenous boss 24 as described below. Flange 46
The anterior intravenous boss 24 is also described below.
It is arranged to cooperate with the upper flange 88. A hole 70 extends into the rear end 25 of the housing. Hole 70 is large enough to accommodate the diameter of second needle cannula 15 and extends into hole 70 (7-) 195 (FIG. 5), which is secured in hole 70 by any suitable method, such as by adhesive. ing. As discussed in more detail below, it is within the scope of the present invention to join the two bosses together by sonic welding or other suitable joining methods known in the art.

As can be seen in FIG. 2, the negative pressure chain 151 terminates at a point 100 positioned to pierce the stopper 21 of the evacuated container 16. Covering the suction end of cannula 15 is a self-sealing resilient sleeve 80 having a flange 92 . Therefore, when a point 100 penetrates the central penetrable septum of the stopper 21, the point 100 first penetrates the distal end of the flexible sleeve 80 and collapses the sleeve 8o as shown in FIG. At this point, the inner surface of the flange 92 adjacent to the cannula 15 is
It has a portion (not shown) that engages with an annular snap-on catch 177 .

This causes the sleeve 8o to fit into the cannula 15 with a snap fit. It will be appreciated that other topologies may also be used.

Referring now to FIG. 5, the intravenous boss 24 includes a bore 29 for receiving the intravenous cannula 14. Boss 24 is
A rear extension portion 117 having a thicker diameter is provided to form a housing chamber 5o for accommodating a blood sample. Extension part 11
At the rear of 7, there is also a cylindrical part 1 which forms a larger internal hole 108 with an offset 119 at the junction of the chamber 5o and the hole 108.
18 are integrally formed.

A hole 30 having a smaller diameter than the hole 29 communicates the hole 29 with the chamber 50 . Offset between holes 29 and 30 3
3 as a sheet for the internal end of the intravenous cannula 14. Extending around the front of the boss 24 are a plurality of ribs 31 that cooperate with internal lips on the shield (not shown) to guide the intravenous needle cannula 14. It is used for coating until it is used.

The vacuum boss 25 forward of the flange 46 includes an integrally formed forward cylindrical extension 111 followed by a forward integrally formed cylindrical extension or hub post 109 . The hub post 109 has a smaller diameter than the extension portion 111, and a recess 110 is formed therebetween. The hub post 109 is connected to the rear extension part 117 of the inner boss part 24,
In cooperation with 118, an annular outflow passage 120 and an annular chamber 5
form 1. The annular chamber 51 forms the portion that accommodates the sleeve or tablet 116 compressed onto the hub post 109 of the present invention as described below. Chamber 51 also serves as a chamber for indicating entry into the vein since the walls of extensions 117 and 118 are transparent or translucent. As mentioned above, the sleeve 116 is manufactured by Grain Processing Corporation.
gCorporation) compressed water lock (WATER-LOCK) A125
It may consist of. As shown in FIG.
, 118 may be formed and disposed on the hub post 109 of the vacuum boss 25 prior to insertion therein.

According to the invention, the hub post 1o9Lri is in the form of a cylindrical compressed tablet or sleeve 116t-supporting columnar boss. Furthermore, since the hub boss l-109 has a tapered surface 114, the columnar boss 109 has a point 1
The diameter gradually increases in the negative pressure direction from 29 to offset D 110. This creates a wedging effect between the tablet sleeve 116 and the surface 114 and the wall of the chamber 51 and the surface 1
A tablet sleeve 116 is supported concentrically with respect to 14. Therefore, the tablet sleeve 116 responds evenly in each ring expansion to flush air pockets from the device and swell immediately upon contact with sample moisture.

Further, with reference to FIG. 5, the central extension 111 of the negative pressure boss 25 has a diameter slightly smaller than the diameter of the hole 108 and is disposed on a flange 88 forming the rearmost end of the internal vacuum boss 24. A ventilation surface track 122 is formed which communicates with the ventilation section 104. The seven flange 46.88 are joined together into a complete assembly by sonic welding at passageway 102. Those skilled in the art will also appreciate that the cooperating grooves 140 and extensions 141 formed in the cooperating flanges 46.88 can be joined together, for example, by an adhesive material.

For illustration purposes only, chamber 5o and chamber 51
The passageway 120 between can have a radius of 0.04M (0.0015 inches). That is, the diameter of the front end of the hub post 109 is 2.8 mm (0,110 inches).
, and the diameter of the chamber 50 formed by the annular extension 117 of the intravenous boss 24 is 2.9wn (0.113 inches). The radius of the outflow passage is 0.04 m (0,0015
inch), but preferably 0.01 city (0,000 inch), but preferably 0.01 city (0,000
5 inches). That is, the diameter of the extension part 111 is 5
．． The diameter of the hole 108 is 0.220 inches.

Additionally, and purely for illustrative purposes, the length of hub post 109 is 7.1 mm (0.028 inches), while the length of tapered surface 114 is 3.9 mm (0.155 mm).
inch). The angle of surface 114 from extension 109 is 1.2°.

That is, it is a Brown-Sharp type taper with a diameter of 12.7M (0,500 inches) per 30 CIrL (1 foot). For an EE compressed tablet or sleeve 116, the length is approximately 2.8
, within the range of 0.110 to 0.149 inches.

The inner diameter of the central opening or hole 112 in the sleeve 116 is not particularly critical to the invention, so long as it is of a suitable length to secure the desired wedge/or seating in the extension 109. For example, the hole 112 is about 2.8 to 2.9
M (0.111 to 0.114 inches). The critical dimensions are the outer surface of sleeve 116 and the outer surface of chamber 51.
This is the gap between the wall and the wall. In general.

The diametrical clearance is approximately 0.003 to 0.10 fl (
0,0001 inch to 0.004 inch), preferably 0.01 to 0.10M (0,000
5 inches to 0.004 inches). Preferably, there is a gap initially to maintain some degree of breathability within a generally small area that includes the swelling reaction of the sleeve or tablet 116 upon contact with moisture. The tablet or sleeve 116 is comprised of compressed powder and is compressed in a die to a density within the range of about 0.8 to 1.1 g/cc. This powder is manufactured by the method described in U.S. Pat. No. 3,661,815 or U.S. Pat. No. 4,159,260.
rain Processing Corporation
Waterlock (VAT ER) is a product of
-LOCK; Trademark) A125. This material is a starch-graft copolymer of hQ IJ acrylic acid and polyacrylamide. It has a density of 0.34 g/cc before being compressed into the tablet sleeve of the present invention. Waterlock A125 has sleeve 1
This is just one example of typical products used for molding.

Turning now to FIG. 6, a representative apparatus for forming a tablet or sleeve 116 of the present invention is shown. It should be understood that this is merely exemplary and that other equipment may be used to compact the representative powder to the desired density.

For example, die 152 is shown disposed on a striker 162 by a locating pin 154, which is held to die 152 by a set screw 160. hole 164 to cooperate with to form the tablet or sleeve 116 of the present invention.
is placed in the center of the It will be appreciated that the density of the tablets 116 formed by such equipment may be varied by varying the stroke length and/or the size of the filler used.

As can be seen from the foregoing description, the blood collection needle assembly of the present invention can be used in conjunction with a device to alert the user of the assembly of entry into a vein, if desired. provided to collect a blood sample. In this regard, tablet- or sleeve-type devices can detect the presence of blood in the chamber of the assembly because the presence of blood in the sleeve is indicated through the transparent or translucent housing wall.
It is useful for expressing things quickly. Due to its size, degree of compaction and/or density, the material readily absorbs blood moisture and swells to the point where it seals the chamber in the housing and prevents leakage of blood. This allows venous blood to flow into the housing chamber from the direct liquid source almost immediately after the remaining air in the housing chamber has been expelled.

The tapered hub bust on which the compressed tablet rests ensures proper alignment and concentricity with the chamber walls and containing hub post, allowing the tablet to react simultaneously with retention, quickly swelling and closing the air passageway to prevent sample leakage. Make sure not to.

Therefore, the escape of replacement air from the chamber and the sealing of the chamber,
The quick indication to the user that proper entry into the patient's vein has been made and that multiple samples have been taken occurs almost instantaneously and simultaneously. Following this display, the user sequentially inserts multiple tubes 16 into the negative pressure cannula 15 with sleeve valve 80 for subsequent removal and inserts another evacuated tube 16 to extract a single blood sample from a single blood source. The present invention provides an automatic sealing device for collecting multiple blood samples through venipuncture.

The device described herein is, of course, a disposable device. Once a single or multiple samples have been taken from a single blood source, they are discarded. In this regard, the device is a very inexpensive and simplified device, with a separate sleeve placed between the 2m parts forming the housing as separate parts of the assembly on a mass production line. It is important to understand that literally thousands of assemblies of the present invention can be produced with high efficiency in a highly mechanized manner. However, although these devices are inexpensive and disposable, they signal venous entry, allow displacement air to exit, and open the housing chamber once venous entry is indicated by the device. To accurately and reliably perform the function of appropriately and completely sealing.

While the device methods and configurations described above constitute preferred embodiments of the invention, the invention is not limited to these precise device methods and configurations, and modifications may be made without departing from the scope of the claims. It can be done.

[Brief explanation of drawings]

FIG. 1 is an exploded perspective view schematically illustrating the standard components and apparatus of a sample collection needle assembly comprising a negative pressure container reservoir holder and a negative pressure blood collection container used to obtain a blood sample from a patient; , FIG. 2 is a partially enlarged cross-sectional view taken along line 2--2 of FIG. 1 showing the separate resilient sleeve valve used in the present assembly, and FIG. FIG. 4 is a perspective view of the needle 1 assembly connected to a holder inserted into the patient so that the user can observe the entry of the assembly into the vein. 5 is an enlarged cross-sectional view of the housing assembly of FIG. 1 with the cannula removed, including a venous boss, a negative pressure boss, and a tapered sleeve of the present invention between them, which is one embodiment of the sleeve; FIG. Figure 6 shows a two-part solid body of a housing in the form of a supporting nozzle post, and Figure 6 shows an apparatus for forming a compressed cylindrical sleeve or tablet forming part of the cylindrical side. FIG. 10: Needle assembly 12: Housing 14.1
5: Needle cannula 16: Negative pressure container 18: Screw
19: Container holder 20: Screw 21: Stopper 24: Intravenous boss portion 25: Negative pressure boss portion 26: Extension portion 29: Hole 46: Flange 50: Housing chamber 111: Cylindrical portion

Claims (13)

[Claims] (1) a needle assembly for collecting one or more liquid samples from a sample source and then discharging the samples in a vacuum container, the housing having a front end and a rear end; a sample collection chamber in the housing; a first inlet opening at the forward end in fluid communication with the sample collection chamber; a first cannula extending toward the sample collection chamber; a second inlet opening disposed at the rear end and communicating with the sample collection chamber; a second cannula in communication with the second cannula; and a valve on the second cannula for controlling discharge of liquid sample from the sample collection chamber into a negative pressure container attached to the second cannula. a cooperating device provided at the front end and the rear end of the housing to provide a fluid outflow passageway therebetween;
a cooperating device having a tapered hub post at the rear end having a cross section that gradually increases from the front end to the rear end and extending into the sample collection chamber; a venting device disposed in the housing and in communication with the fluid outflow passageway and ambient air; an annular compressed tablet disposed in the hub post comprising a material responsive to a moisture-containing substance introduced into the sample collection chamber; a tablet for swelling in contact with a moisture-containing material passing through the fluid exit passageway to close the passageway, such that the first cannula engages the sample source. A liquid containing water then enters the sample collection chamber, forcing the gas in the sample collection chamber through the fluid outlet passageway and the venting device, causing the liquid to contact the tablet and cause it to swell and exit the fluid outlet passageway. A needle assembly characterized in that it is configured to close. (2) In the needle assembly according to claim 1,
The cooperation device includes: an integrally formed cylindrical extension on the rear end of the housing; and an integral annular extension on the forward end of the housing; A needle assembly characterized in that the inner surface and the outer surface of the trailing end cooperate to form an annular fluid exit passageway arrangement therebetween. (3) In the needle assembly according to claim 1,
A needle assembly characterized in that said tablet consists of an annular compressed tablet of hydrolyzed starch-polyacrylonitrile graft copolymer having side chains containing carboxamide and carboxylate groups. (4) In the needle assembly according to claim 3,
A needle assembly wherein said annular tablet is comprised of compacted powder to a density within the range of about 0.80 to 1.1 g/cc. (5) In the needle assembly according to claim 1,
The loose fit gap between the compressed tablet and the wall of the chamber containing the tablet is about 0.003 mm to 0.00 mm.
．． 1mm (0.0001 inch to 0.004 inch)
A needle assembly characterized in that it is within the range of. (6) In the needle assembly according to claim 5,
The motion fit is about 0.01 mm to 0.1 mm (0.0
0.005 inch to 0.004 inch). (7) In the needle assembly according to claim 1,
A needle assembly characterized in that said housing comprises a device for connecting a holder of a negative pressure container. (8) In the needle assembly according to claim 1,
A needle assembly comprising a negative pressure container holder connected to the housing. (9) In the needle assembly according to claim 1,
A needle assembly comprising a device for observing the content of the sample collection chamber. 10. The needle assembly of claim 9, wherein the viewing device is a transparent or translucent housing wall near the sample collection chamber. (11) The needle assembly of claim 1, wherein the hub post has a tapered surface, and the tapered surface has an angle of 1.2° from the axis of the hub post. A needle assembly characterized by: (12) In the diagonal assembly according to claim 11, the length of the tapered surface is 3.9 mm (0.15 mm).
5 inches). (13) The needle assembly according to claim 1, wherein the annular compressed tablet has a diameter of about 2.8 to
A needle assembly characterized in that it is within the range of 2.9 mm (0.111 to 0.114 inches).